The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) is an initiative of Public Health England (PHE). We have provided a briefing for PHE about the models of consent that would be used for the register.
In November 2013, the department of Health published the UK Strategy for Rare Diseases. In this strategy all four Governments of the UK committed to improving systems for the recording of incidence and prevalence of disease, to standardise data collection, and support patients to register on databases. These commitments recognise the important role that data sharing and research has to play in addressing the high level of unmet medical need within the rare disease community, and has led to the creation of NCARDRS. NCARDRS will combine existing regional registers, and will fill the gaps that currently exist in some areas of the UK.
Using insights from the project My Condition, My DNA, we have produced a briefing for PHE to highlight our view on the model of consent that should be used for this register. We support the use of the statutory power defined in Section 251 of the NHS Act 2006 for data collection for NCARDRS. This provides the statutory power to allow NHS patient identifiable information to be used without the consent of patients where it is needed to support essential NHS activity, but where gaining consent is not practicable. This is because we think it is crucial to the interests of the genetic and rare disease community that NCARDRS can create a data set that is as complete as possible.